Cease of distribution of AstraZeneca Nebuchamber  

13 April 09

AstraZeneca AB has identified an issue with the Nebuchamber device, which is an inhalation aid used with AstraZeneca’s pressurised metered dose inhaler Pulmicort. The device consists of a mouthpiece and a metal spacer.
The problem is the possibility to connect the mouthpiece to the metal spacer in the wrong direction, in which case the valve cannot be opened and no treatment can be administered.
AstraZeneca has suspended further distribution of this device from stock within its control.
AstraZeneca recommends that all batches of the Nebuchamber be recalled from wholesalers, pharmacies and hospitals. The recall will prevent new patients from receiving the device.
For existing patients, Astra Zeneca will request doctors to proactively contact existing patients and arrange to switch the patient to another device or if an alternative device is not available to an alternative product. AstraZeneca is also requesting pharmacists to contact existing patients known to be given the Nebuchamber device, and either arrange for the patient to obtain an alternative device, or ask the patient to consult their doctor for advice. Where immediate switch of device is not possible, AstraZeneca will invite pharmacists and doctors to emphasise to patients the importance of correct assembly of the Nebuchamber device.

The manufacturer is working on a solution to change the construction of the device and is adding a further safety notice in the user’s manual.

Further information: info@ravimiamet.ee, phone +372 737 4140.